BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUM 1.6 W/ DATAPORT

    MDR report key: 1938642 · Received December 15, 2010

    Report

    Report Number
    2921482-2010-01012
    Event Type
    Death
    Date Received
    December 15, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 18, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K911401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. IT WAS REPORTED THE PATIENT WAS BEING TREATED STATUS POST CARDIAC ARREST, AND THE PHYSICIAN ORDERED THAT THE PATIENT BE STARTED ON LIDOCAINE THERAPY. THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF LIDOCAINE, AT A RATE OF 30ML/HR, VIA ONE OF THE PATIENT'S MULTIPLE IV ACCESS SITES AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT'S STATUS BEGAN TO "DETERIORATE" AND THE PHYSICIAN ORDERED THAT THE LIDOCAINE DELIVERY BE DISCONTINUED AND THE PATIENT TO RECEIVE AN UNSPECIFIED CONCENTRATION OF PLASMANATE. IT WAS REPORTED THE LIDOCAINE DELIVERY WAS STOPPED AND THE CASSETTE OF THE TUBING SET WAS REMOVED FROM THE DEVICE. THE DEVICE WAS THEN REPROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF PLASMANATE VIA ONE OF THE PATIENT'S OTHER ACCESS SITES AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT WENT INTO A SECOND CARDIOPULMONARY ARREST. AT THIS TIME, IT WAS NOTED THAT THE LIDOCAINE CONTAINER WAS EMPTY AND THAT THE TUBING SET WAS STILL CONNECTED TO THE PATIENT'S IV ACCESS SITE. THE CUSTOMER CONTACT INDICATED THAT AFTER THE CASSETTE WAS REMOVED FROM THE DEVICE, THE FLOW REGULATOR DID NOT CLOSE PROPERLY AND THE LIDOCAINE CONTINUED TO FLOW. THE PATIENT EXPIRED AT AN UNSPECIFIED TIME DURING THE CODE. THE CUSTOMER CONTACT INDICATED THAT THE PATIENT'S CONDITION WAS SO POOR THAT THE LIDOCAINE WAS NOT THE CAUSE OF THE SECOND CARDIOPULMONARY ARREST. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM 1.6 W/ DATAPORT 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death LIDOCAINE - MFR UNK